Pharmaceutical innovation must align with patient needs

Copenhagen and Geneva, 16 July 2013

For the first time, more people in European Union (EU) countries are aged over 65 years than under 15 years. Much of the rest of the world, including low-and middle-income countries, is moving in a similar direction. A new WHO report calls for pharmaceutical researchers to adjust their research and development work to take account of this shift.

The report, “Priority medicines for Europe and the world: 2013 update”, emphasizes that this shift in EU countries is a bellwether for the rest of the world, as more people globally will age and face similar health challenges in the future.

The report focuses on pharmaceutical gaps, where treatments for a disease or condition may soon become ineffective, are not appropriate for the target patient group, do not exist or are not effective enough.

Insufficient pharmaceutical innovation

“Despite an over three-fold rise in spending on pharmaceutical research and development in Europe since 1990, there is an increasing mismatch between people’s real needs and pharmaceutical innovation. We must ensure that industry develops safe, effective, affordable and appropriate medicines to meet future health needs,” says Nina Sautenkova, Manager of Health Technologies and Pharmaceuticals at WHO/Europe.

From a public health point of view, the trend towards an increasing population over 65 leads to a greater prevalence of diseases and conditions associated with ageing, such as heart disease, stroke, cancer, diabetes, osteoarthritis, low back pain, hearing loss and Alzheimer’s disease. In combination with health promotion and disease prevention initiatives, these conditions require more investment in research and innovation to bridge the pharmaceutical gaps. Since the original report was published in 2004, progress has been mixed.

Investment needed in large-scale trials

Patients, particularly elderly people, often require medication for multiple chronic conditions, but research and treatment guidelines tend to be more disease driven than patient centred.

“Multiple small-scale trials of combination therapy have been undertaken, but no large-scale studies have been initiated. One such example is fixed-dose polypills for ischaemic heart disease (or myocardial ischaemia),” says Kees De Joncheere, Director of the Essential Medicines and Products Department at WHO headquarters. “Although there are some promising results from small trials, we need investment in large-scale trials to have the evidence to see if we can get the right formulations and make this work in practice to save more lives.”

Areas for future research

In addition to conditions related to ageing, the report identifies a number of other important topics for future pharmaceutical research. One is the need for more medicines that do not require storage in cool temperatures, such as heat-stable insulin for diabetes and oxytocin for childbirth. These would provide an important benefit to health services in countries without consistent access to refrigeration.

As identified in the 2004 report, the increasing resistance of common microbes to the medicines used to treat them, called antimicrobial resistance, threatens to make many current health care interventions impossible. There is an urgent need not only to preserve current medicines but also to develop new options.

Other highlights of the report include additional critical factors in pharmaceutical innovation, such as: optimizing regulatory systems for market authorization, adopting effective pricing and reimbursement policies to create incentives, and leveraging existing electronic health records to obtain valuable data to improve medicine safety and effectiveness. Within Europe, there are moves towards adaptive licensing and value-based pricing that may change access to and incentives for new medicines. Finally, the report stresses the need for meaningful patient and citizen involvement in pharmaceutical innovation and access.

“Priority medicines for Europe and the world: 2013 update” is an update to a 2004 report and the collaborative product of experts from WHO, EU Member States, industry and academe and of other interested stakeholders, including patients.

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